Senior RD Engineer

Senior R&D EngineerMaple Grove, MN | Direct-Hire | $100,000-$130,000 | 100% Onsite

Position OverviewWe are seeking a highly skilled Senior R&D Engineer to play a critical role in driving innovation and advancing product development initiatives. This position will lead projects from concept through commercialization, transforming ideas into impactful medical device solutions. The Senior R&D Engineer will act as a technical leader, collaborating with cross-functional teams to ensure designs meet quality, regulatory, and patient needs while also contributing to mentoring and team development within the engineering department.

Key Responsibilities

• Lead the design, development, and testing of medical devices from ideation through commercialization.
• Serve as the technical lead on multiple projects, providing direction and oversight throughout the product lifecycle.
• Develop and evaluate prototype devices to assess technical feasibility, functionality, and manufacturability.
• Translate user and patient requirements into detailed engineering specifications that align with verification and validation standards.
• Create and validate robust test methods, fixtures, and protocols to support product evaluation.
• Document and communicate progress, findings, and recommendations to stakeholders across departments.
• Engage with healthcare professionals to gather insights and ensure solutions address real-world applications.
• Collaborate with suppliers for component sourcing and maintain strong vendor relationships.
• Oversee verification and validation activities in support of regulatory submissions and design transfer.
• Support portfolio growth through product line extensions, design improvements, and innovation initiatives.
• Mentor and support junior engineers and peers to elevate team technical capabilities.

Minimum Qualifications

• Bachelor’s degree in Engineering or a related field with 5+ years of relevant experience, or 8+ years of technical experience in product development.
• Strong problem-solving and analytical skills with demonstrated success in product design.
• Excellent communication skills with the ability to clearly convey technical information across teams.
• Proven ability to manage multiple projects independently and meet deadlines in a fast-paced environment.
• Familiarity with statistical analysis methods to support engineering decision-making.
• Proficiency in CAD (SolidWorks preferred), Microsoft Excel, and database tools.
• Hands-on experience with lab and measurement equipment such as calipers, micrometers, and tensile testers.
• Knowledge of US and international medical device regulatory requirements and quality systems.

Preferred Skills

• Experience with medical device manufacturing processes, including extrusion and injection molding.
• Strong knowledge of design controls, project management methodologies, and quality system practices.
• CAD design expertise, preferably in SolidWorks.
• Familiarity with clinical applications and ability to convert them into detailed design requirements.
• Proven track record in guiding medical devices through development to successful market launch.

Benefits & Compensation

• Comprehensive health, dental, and vision coverage.
• 401(k) plan with company match.
• Paid time off, including vacation, holidays, and personal days.
• Life insurance, disability coverage, and additional voluntary benefits.
• Professional development opportunities and a collaborative work environment.

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Konik is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as a qualified individual with a disability, or any other protected class status.

Konik has been creating impactful relationships between technical talent and employers for more than 50 years. Konik has specialized in placing professional, qualified personnel in Minnesota and western Wisconsin businesses since its inception, and maintains a strong commitment to customer service.

Compensation:
$100,000-$130,000 per year